Duns Number:109903521
Device Description: DYONICS SST STD TWIST DRILL 2.0MM X 127M
Catalog Number
72204431
Brand Name
DYONICS
Version/Model Number
72204431
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
b4536e5a-d98b-444b-a1ee-978202b42b2a
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
October 05, 2015
Package DI Number
20885554036118
Quantity per Package
6
Contains DI Package
00885554036114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |